VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial o

The firm, Cyberonics Inc., initiated containment actions on March 17, 2011 to prevent additional affected devices from being shipped. The firm initiated contact with implanting facilities in the United States on May 6, 2011 and international facilities and distributors on May 10, 2011 to remove product from the field that has not yet been implanted. Additionally, a "Field Safety Alert" letter was sent to all affected medical professionals. The letter identifies the affected product, the issue, and the action(s) to be taken by the physicians. Consignees are instructed to complete and return an attached Effectiveness Check Form. If assistance is needed physicians may contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com